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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05324527
Other study ID # MersinUniv
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2017
Est. completion date September 1, 2017

Study information

Verified date April 2022
Source Mersin University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study was conducted randomly controlled experimental to determine the effect of hand massage applied to pre-operative children on anxiety level and physical symptoms of anxiety.


Description:

On operation morning, "Child and Parent Introduction Form", "State-Trait Anxiety Inventory for Children" were read to and "Physiological Symptoms of Anxiety Inspection Form" measurement was done on children in both groups, and their 1st measurement values were recorded. Routine treatment and nursing care applications of the service were done preoperationally. After the researcher and the children in study group sat on a chair facing each other, hand massage procedure, 8 minutes to both hands and a total of 16 minutes hand massage was applied with liquid petrolatum. No massage was applied to children in control group. Right 16 minutes after the 1st filled forms in each group, "State-Trait Anxiety Inventory for Children", "Physiological Symptoms of Anxiety Inspection Form" were read, measurement was done and 2nd measurement values were recorded. Furthermore, "Satisfaction Evaluation Scale" was marked by those in study group after the massage, and measurement values were recorded.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date September 1, 2017
Est. primary completion date September 1, 2017
Accepts healthy volunteers No
Gender All
Age group 9 Years to 12 Years
Eligibility Inclusion Criteria: - Agreeing to participate in the study and obtaining written permission from the family, - Able to speak and understand Turkish, - Not taking any analgesic and anesthetic drugs before the procedure, - Over 9 years old and under 12 years old, - whose parents are literate, - Poor general condition and not needing emergency surgery (cases such as acute abdomen, intestinal perforations, traumas, etc.), - There is no open wound on the skin or an obstacle to massage (edema, abscess, skin infection with necrosis, etc.), - Thrombophlebitis, occlusive artery disease, fever etc. who do not have a situation in which massage application is objectionable due to illness, He does not have conditions such as loss of sensation, mass, fracture and ingrown nails in his hand, - Children who are conscious, fully oriented and cooperative and open to communication Exclusion Criteria: - Those who do not accept to participate in the research and do not get written permission from their families, - Does not speak or understand Turkish - Taking any analgesic and anesthetic drugs before the procedure, - Less than 9 years old and over 12 years old, - illiterate parents - Poor general condition and emergency surgery (acute abdomen, intestinal perforations, traumas, etc.) cases) need, - Open wound on the skin or an obstacle to massage (edema, abscess, necrosis has occurred) skin infection etc.) - Thrombophlebitis, occlusive artery disease, fever etc. massage practice due to illness having a situation where it is objectionable, - Having conditions such as loss of sensation in the hand, mass, fracture and ingrown nails, - Children who are unconscious, oriented and cooperative and not open to communication

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Hand Massage
Hand massage procedure, 8 minutes to both hands and a total of 16 minutes hand massage was applied with liquid petrolatum.

Locations

Country Name City State
Turkey Mersin University Mersin

Sponsors (1)

Lead Sponsor Collaborator
Mersin University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anxiety evaluated using the State Anxiety Scale Scores ranging from 20 to 80 points are obtained in the scale. In the total score obtained from the scale in scoring the scale, 0-19 points indicate the absence of anxiety, 20-39 points indicate mild anxiety, 40-59 points indicate moderate anxiety, and 60-79 points indicate severe anxiety level. Higher state anxiety scores indicate that anxiety level is also hig Change from before implementation and after 16 minutes of practice (hand massage)
Secondary Blood pressure systolic blood pressure (SBP), diastolic blood pressure (DBP), mmHg Change from before implementation and after 16 minutes of practice (hand massage)
Secondary Heart rate beats per minute Change from before implementation and after 16 minutes of practice (hand massage)
Secondary respiratory rate ekspiration and inspiration per minute Change from before implementation and after 16 minutes of practice (hand massage)
Secondary peripheral oxygen saturation %, percentage of oxygenated hemoglobin in peripheral arterial blood Change from before implementation and after 16 minutes of practice (hand massage)
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